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Commissioning & Qualification Services
Our quality and validation team have extensive practical knowledge and experience in current regulatory requirements (FDA/EMA/Chinese NMPA/cGMP) and local regulations. In combination with the modular facility delivery, commissioning and parts of the IQ/OQ are performed at the equipment suppliers` workshop, and in our own assembly facilities.
The final steps of qualification are performed at the final site, often together with the client`s QA and validation team. This allows for a fast delivery without compromising quality.
We have developed an extended V-model. This V-model offers seamless integration of Quality by Design (QbD) as defined by ICH Q8 Pharmaceutical Development and a modern risk-based approach as defined in ICH Q9 Quality Risk Management and GAMP 5 Risk-Based Approach to Compliant GxP Computerized Systems.